Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Subjects were randomized at 118 investigational sites in 17 countries.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

1549 patients were assessed for eligibility of whom 796 subjects were randomized in a 4.3:4.3:1 ratio to receive generic glatiramer acetate (GTR), brand glatiramer acetate (Copaxone) or matching placebo. Two subjects were randomized to the generic glatiramer acetate group but did not start treatment and were not enrolled.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Glatiramer 20 mg

Glatiramer Acetate (GTR) 20 mg daily for 9 months

Copaxone 20 mg

Glatiramer Acetate (Copaxone) 20 mg daily for 9 months

Placebo

Placebo (daily) for 9 months

Total

Total of all reporting groups

Baseline Measures

Glatiramer 20 mg

Copaxone 20 mg

Placebo

Total

Overall Participants Analyzed [Units: Participants]

353

357

84

794

Age [Units: Years]Mean (Standard Deviation)

32.6 (8.6)

33.8 (9.0)

32.6 (8.7)

33.1 (8.8)

Gender [Units: Participants]

Female

233

238

57

528

Male

120

119

27

266

Time from first clinical event to randomization [Units: Years]Mean (Standard Deviation)

5.5 (5.3)

6.4 (6.0)

5.7 (6.0)

5.9 (5.7)

Number of relapses in period within 2 year prior to signing ICF [Units: Number of relapses]Mean (Standard Deviation)

1.9 (0.9)

1.8 (0.9)

1.9 (0.9)

1.8 (0.9)

Outcome Measures

1. Primary:

The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 [ Time Frame: 9 months ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
The terms and conditions of Synthon's agreements with its investigators may vary. However, Synthon BV does not prohibit any investigator from publishing. Any publication from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.